Helping patients quit smoking: Lessons from the EAGLES trial

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Psychiatrists often fail to adequately address their patients’ smoking, and often underestimate the impact of ongoing tobacco use. Evidence suggests that heavy smoking is a risk factor for major depressive disorder; it also is associated with increased suicidal ideations and attempts.1,2 Tobacco use also has a mood-altering impact that can change the trajectory of mental illness, and alters the metabolism of most psychotropics.

Previously, psychiatrists may have been reluctant to prescribe the most effective interventions for smoking cessation—varenicline and bupropion—because these medications carried an FDA “black-box” warning of neuropsychiatric adverse effects, including increased aggression and suicidality. However, a large study called the EAGLES trial3 found that the neuropsychiatric risks associated with these medications were lower than previously thought. Consequently, in December 2016, the FDA removed the black-box warning related to serious mental health adverse effects from the labeling of varenicline and bupropion.4

The EAGLES trial was a large, multi-site global trial that included patients with and without mental illness. Its primary objective was to assess the risk of “clinically significant” adverse effects for individuals receiving varenicline, bupropion, nicotine replacement therapy (NRT), or placebo, and whether having a history of psychiatric conditions increased the risk of developing adverse effects when taking these therapies. Overall, 2% of smokers without mental illness experienced adverse effects, compared with 5% to 7% in the psychiatric cohort, regardless of treatment arm. The rate of neuropsychiatric events and scores on suicide severity scales were similar across treatment arms in both cohorts.3

We should take lessons from the EAGLES trial. We propose that clinicians ask themselves the following 6 questions when forming a treatment plan to address their patients’ tobacco use:

1. Does the patient meet DSM-5 criteria for nicotine use disorder and, if yes, what is the severity of his or her nicotine dependence? The Fagerstrom Test for Nicotine Dependence (FTND)5 is a 6-question instrument for evaluating the quantity of cigarette consumption, compulsion to use, and dependence. It provides clinicians with guidelines on preventing withdrawal by implementing NRTs, such as lozenges, an inhaler, patches, and/or gum. A score of 1 to 2 (low dependence) indicates that no NRT is needed; a score of 3 to 4 (low to moderate dependence) requires 1 NRT; and scores of 5 to 7 (moderate dependence) and ≥8 (high dependence) require a combination of NRTs.

In the EAGLES trial, all participants smoked at least 10 cigarettes per day, and had moderate dependence, with an average FTND score of 5 to 6.

2. What stage of change is the patient in, and how many times has he or she attempted to quit? Based on the answers, motivational interviewing may be appropriate.

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